Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

NCT06531109 | Recruiting

• 2 other identifiers: B7981105NCT06531109
• Study Type: observational
• Target: 850
• Locations: 5 countries
• Sites: 58

Brief Summary

Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are:

• Patchy alopecia (PA), as seen in 90% of clinical diagnoses
• Alopecia totalis (AT), that affects all scalp hair
• Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020). Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally. Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib. The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24

  SALT score is used to calculate the severity of alopecia areata. Physician calculate it by summing the percentage of hair loss in different regions of scalp.

  24 weeks from initiation of the treatment

Secondary Outcomes (24)

• Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status

  Baseline

• Demographic Characteristic of Participants: Date of Initial AA diagnosis

  Baseline

• Demographic Characteristics of participants: Duration of AA since diagnosis

  Baseline

• Demographic characteristics of participants: Duration of current AA Episode

  Baseline

• Demographic Characteristic of Participants: Predominant AA phenotype

  Baseline

Study Arms (1)

Alopecia Areata (AA) patients treated with ritlecitinib

Drug: Ritlecitinib

Interventions

Ritlecitinib DRUG

As provided in the real world practice.

Alopecia Areata (AA) patients treated with ritlecitinib

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population eligible for enrollment includes any adult and adolescent patients aged ≥12 years diagnosed with AA who receive at least one dose of ritlecitinib and satisfy the inclusion and exclusion criteria. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study. It will be allowed to enroll patients with previous use of topical JAK inhibitors only if there was at least a 4-week wash-out period prior to Baseline Visit

You may qualify if:

• Male and female patients aged \>12 years at baseline.
• Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
• Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.

You may not qualify if:

• Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium).
• Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
• Patients previously treated with ritlecitinib or other JAK inhibitors.
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (58)

C2 Research Center

Montgomery, Alabama, 36117, United States

RECRUITING

CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

Fremont, California, 94538, United States

RECRUITING

Rao Dermatology

Fresno, California, 93720, United States

RECRUITING

Cura Clinical Research

Oxnard, California, 93030, United States

RECRUITING

Stanford

Redwood City, California, 94063, United States

NOT YET RECRUITING

Southern California Clinical Research

Santa Ana, California, 92701, United States

RECRUITING

Dermatology of Boca

Boca Raton, Florida, 33431, United States

RECRUITING

Pediatric Skin Research,LLC

Coral Gables, Florida, 33146, United States

RECRUITING

Suncoast Skin Solutions

Jacksonville, Florida, 32256, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Skin Research of South Florida LLC

Miami, Florida, 33173, United States

RECRUITING

Kindred Hair and Skin Center

Marriottsville, Maryland, 21104, United States

RECRUITING

Brigham & Women's Hospital/Harvard Medical School

Boston, Massachusetts, 02115, United States

RECRUITING

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

RECRUITING

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

RECRUITING

Twin Cities Dermatology Center

Minneapolis, Minnesota, 55416, United States

ACTIVE NOT RECRUITING

Hickory Dermatology Research Center

Hickory, North Carolina, 28602, United States

RECRUITING

NW Dermatology Institute

Portland, Oregon, 97210, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

RECRUITING

Epiphany Dermatology

Southlake, Texas, 76092, United States

RECRUITING

Raven Clinical Reseach

Fairfax, Virginia, 22033, United States

RECRUITING

Raven Clinical Reseach

McLean, Virginia, 22102, United States

RECRUITING

Frontier Dermatology

Mill Creek, Washington, 98012, United States

RECRUITING

Raven Clinical Reseach

Burlington, Wisconsin, 53105, United States

RECRUITING

Beijing Tongren Hospital

Beijing, 100006, China

RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

The Fist Hospital of Jilin Province

Changchun, 130021, China

NOT YET RECRUITING

Xiangya Hospital, Central South University

Changsha, 410028, China

RECRUITING

Dermatology Hospital of Southern Medical University

Guangzhou, 510091, China

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

RECRUITING

Shanghai Skin Disease Hospital

Shanghai, 200443, China

RECRUITING

Ch Victor Dupouy

Argenteuil, 95100, France

NOT YET RECRUITING

CHU de CAEN

Caen, 14033, France

RECRUITING

Chu Dijon Bourgogne

Dijon, 21000, France

NOT YET RECRUITING

CHU de Grenoble Alpes

La Tronche, 38700, France

NOT YET RECRUITING

CHU de Rennes Hôpital Pontchaillou

Rennes, 35000, France

NOT YET RECRUITING

Rouen University Hospital

Rouen, 76000, France

RECRUITING

Centre Sabouraud

Paris, Île-de-France Region, 75010, France

NOT YET RECRUITING

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, 807-8556, Japan

RECRUITING

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

RECRUITING

Nagomi Dermatology Clinic

Ebina, Kanagawa, 243-0432, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 908-8574, Japan

NOT YET RECRUITING

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-0051, Japan

RECRUITING

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Teikyo University Hospital

Itabashi-Ku, Tokyo, 173-8606, Japan

NOT YET RECRUITING

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 160-0023, Japan

NOT YET RECRUITING

University Hospitals Sussex

Brighton, EAST SUSSEX, BN2 3EW, United Kingdom

NOT YET RECRUITING

NHS Fife

Dunfermline, FIFE, KY120SU, United Kingdom

NOT YET RECRUITING

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, GLOUCESTERSHIRE, GL13PX, United Kingdom

RECRUITING

Chelsea and Westminster NHS Foundation Trust

London, London, SW10 9NH, United Kingdom

RECRUITING

Royal United Hospital Bath

Bath, BA1 3NG, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, G4 0SF, United Kingdom

RECRUITING

Whipps Cross (Barts Health)

London, E11 1NR, United Kingdom

RECRUITING

London North West University Healthcare Trust

London, NW10 7NS, United Kingdom

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 31, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); CN (8); US (25); JP (10); GB (8)